Germany· DE-A57-5e5a834e8b716227
Novaminsulfon Lichtenstein
A medicinal product containing metamizole sodium monohydrate, registered in Germany by Winthrop Arzneimittel Gmbh.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Metamizole Sodium Monohydrate
- Manufacturer
- Winthrop Arzneimittel Gmbh
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Metamizole sodium monohydrate in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaAFEXILZentiva, k.s., Praha
- SpainALGI-MABO 0,4 G/ML SOLUCIÓN INYECTABLE Y PARA PERFUSIÓNMabo Farma S.A.
- NorwayMetamizol hexalHexal
- NetherlandsDolamizol 250 mg, tabletAll-Gen Pharmaceuticals & Generics B.V.
- BelgiumNovalgine 1000 mg/2 mlOpella Healthcare Belgium
Authorised across Europe · EMA
The same active substance is authorised in 16 EEA countries. Names it is sold under:
- Austria · Metagelan, Metamizol +pharma
- Belgium · Novalgine, Novalgine I.M./I.V.
- Bulgaria · Hexalgin, Аналгин Макс
- Czechia · Afexil, Algominal
- Spain · Metamizol Basi, Metamizol Normon
- Greece · Elgopas
- Croatia · Alkagin, Analgin
- Hungary · Algopyrin, Dolosped
- Lithuania · Analgin, Metamizole Sodium Kalceks
- Luxembourg · Novalgine I.M./I.V.
- Netherlands · Dolamizol, Metamizol Kalceks
- Poland · Algedon, Axonalgin
- Portugal · Dolocalma, Metamizol Aristo
- Romania · Algiotop, Algocalmin
- Slovenia · Algominal, Analgin
- Slovakia · Emitazem, Metamistad
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of EMA Article 57 (European Union). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/f26e04fd-56ed-4b3b-83b7-57f6d5189a41 GET /v1/drugs/f26e04fd-56ed-4b3b-83b7-57f6d5189a41?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"pzn": null,
"route": "Rectal Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Metamizole Sodium Monohydrate",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about metamizole sodium monohydrate.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.